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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Arthrex® - 00888867132559

ANKLE FRACTURE SYSTEM IMPLANT SET
ARTHREX, INC.
AR-8943I
In Commercial Distribution

  • 00888867132559 ()
  • M150AR8943I0 ()
AR-8943I

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Arthrex® - 00888867132542

LOCKING STRAIGHT PLATE, SS, 11H
ARTHREX, INC.
AR-8943C-11
Not in Commercial Distribution

  • 00888867132542 ()
  • M150AR8943C110 ()
AR-8943C-11

  • Orthopaedic fixation plate, non-bioabsorbable

Arthrex® - 00888867132535

LOCKING STRAIGHT PLATE, SS, 9H
ARTHREX, INC.
AR-8943C-09
Not in Commercial Distribution

  • 00888867132535 ()
  • M150AR8943C090 ()
AR-8943C-09

  • Orthopaedic fixation plate, non-bioabsorbable

Arthrex® - 00888867132528

LOCKING STRAIGHT PLATE, SS, 5H
ARTHREX, INC.
AR-8943C-05
Not in Commercial Distribution

  • 00888867132528 ()
  • M150AR8943C050 ()
AR-8943C-05

  • Orthopaedic fixation plate, non-bioabsorbable

Arthrex® - 00888867132511

SIZING TMPLT,DISTAL FIBULA PLT,RT/LFT
ARTHREX, INC.
AR-8943BT
In Commercial Distribution

  • 00888867132511 ()
AR-8943BT

  • Surgical implant template, reusable

Arthrex® - 00888867132504

LOCK DISTAL FIB PLT,SS RT,14H, STERILE
ARTHREX, INC.
AR-8943BRS-14
In Commercial Distribution

  • 00888867132504 ()
  • M150AR8943BRS141 ()
AR-8943BRS-14

  • Orthopaedic fixation plate, non-bioabsorbable

Arthrex® - 00888867132498

LOCK DISTAL FIB PLT,SS RT,12H, STERILE
ARTHREX, INC.
AR-8943BRS-12
In Commercial Distribution

  • 00888867132498 ()
  • M150AR8943BRS121 ()
AR-8943BRS-12

  • Orthopaedic fixation plate, non-bioabsorbable

Arthrex® - 00888867132481

LOCK DISTAL FIB PLT,SS RT,10H, STERILE
ARTHREX, INC.
AR-8943BRS-10
In Commercial Distribution

  • 00888867132481 ()
  • M150AR8943BRS101 ()
AR-8943BRS-10

  • Orthopaedic fixation plate, non-bioabsorbable

Arthrex® - 00888867132450

LOCK DISTAL FIBULA PLT,SS RT,10H
ARTHREX, INC.
AR-8943BR-10
In Commercial Distribution

  • 00888867132450 ()
  • M150AR8943BR100 ()
AR-8943BR-10

  • Orthopaedic fixation plate, non-bioabsorbable

Arthrex® - 00888867132443

LOCK DISTAL FIBULA PLT,SS RT,7H
ARTHREX, INC.
AR-8943BR-07
In Commercial Distribution

  • 00888867132443 ()
  • M150AR8943BR070 ()
AR-8943BR-07

  • Orthopaedic fixation plate, non-bioabsorbable

Arthrex® - 00888867132436

LOCK DISTAL FIBULA PLT,SS RT,3H
ARTHREX, INC.
AR-8943BR-03
In Commercial Distribution

  • 00888867132436 ()
  • M150AR8943BR030 ()
AR-8943BR-03

  • Orthopaedic fixation plate, non-bioabsorbable

Arthrex® - 00888867132429

LOCK DISTAL FIB PLT,SS LFT,14H, STERILE
ARTHREX, INC.
AR-8943BLS-14
In Commercial Distribution

  • 00888867132429 ()
  • M150AR8943BLS141 ()
AR-8943BLS-14

  • Orthopaedic fixation plate, non-bioabsorbable

Arthrex® - 00888867132412

LOCK DISTAL FIB PLT,SS LFT,12H, STERILE
ARTHREX, INC.
AR-8943BLS-12
In Commercial Distribution

  • 00888867132412 ()
  • M150AR8943BLS121 ()
AR-8943BLS-12

  • Orthopaedic fixation plate, non-bioabsorbable

Arthrex® - 00888867132405

LOCK DISTAL FIB PLT,SS LFT,10H, STERILE
ARTHREX, INC.
AR-8943BLS-10
In Commercial Distribution

  • 00888867132405 ()
  • M150AR8943BLS101 ()
AR-8943BLS-10

  • Orthopaedic fixation plate, non-bioabsorbable

Arthrex® - 00888867132375

LOCK DISTAL FIBULA PLT,SS LFT,10H
ARTHREX, INC.
AR-8943BL-10
In Commercial Distribution

  • 00888867132375 ()
  • M150AR8943BL100 ()
AR-8943BL-10

  • Orthopaedic fixation plate, non-bioabsorbable

Arthrex® - 00888867132368

LOCK DISTAL FIBULA PLT,SS LFT,7H
ARTHREX, INC.
AR-8943BL-07
In Commercial Distribution

  • 00888867132368 ()
  • M150AR8943BL070 ()
AR-8943BL-07

  • Orthopaedic fixation plate, non-bioabsorbable

Arthrex® - 00888867132351

LOCK DISTAL FIBULA PLT,SS LFT,3H
ARTHREX, INC.
AR-8943BL-03
In Commercial Distribution

  • 00888867132351 ()
  • M150AR8943BL030 ()
AR-8943BL-03

  • Orthopaedic fixation plate, non-bioabsorbable

Arthrex® - 00888867132344

ATTACHMENT SCREW, AIMING GUIDE
ARTHREX, INC.
AR-8943-46
In Commercial Distribution

  • 00888867132344 ()
AR-8943-46

  • Surgical drill guide, reusable

Arthrex® - 00888867132337

SCREW SLEEVE FOR 3MM DRIVER SHAFT
ARTHREX, INC.
AR-8943-45
In Commercial Distribution

  • 00888867132337 ()
AR-8943-45

  • Surgical drill guide, reusable

Arthrex® - 00888867132320

ANKLE FRACTURE SYSTEM LID
ARTHREX, INC.
AR-8943-44C
In Commercial Distribution

  • 00888867132320 ()
AR-8943-44C

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867132313

SYNDESMOSIS CLAMP
ARTHREX, INC.
AR-8943-44
In Commercial Distribution

  • 00888867132313 ()
AR-8943-44

  • Bone approximation clamp

Arthrex® - 00888867132306

HOHMANN RETRACTOR, 15MM
ARTHREX, INC.
AR-8943-22
Not in Commercial Distribution

  • 00888867132306 ()
AR-8943-22

  • Hand-held surgical retractor, reusable

Arthrex® - 00888867132290

Depth Device, 2.7/3.5/4.0mm, Slider Asm
ARTHREX, INC.
AR-8943-15-1
In Commercial Distribution

  • 00888867132290 ()
AR-8943-15-1

  • Surgical depth gauge, reusable

Arthrex® - 00888867132283

MIDFOOT PLATING MODULE INSTRUMENT SET
ARTHREX, INC.
AR-8941S
In Commercial Distribution

  • 00888867132283 ()
AR-8941S

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Arthrex® - 00888867132269

PLANTAR LAPIDUS PLATE, STANDARD RIGHT
ARTHREX, INC.
AR-8941PR
In Commercial Distribution

  • 00888867132269 ()
  • M150AR8941PR0 ()
AR-8941PR

  • Orthopaedic fixation plate, non-bioabsorbable

Arthrex® - 00888867132245

PLANTAR LAPIDUS PLATE, STANDARD LEFT
ARTHREX, INC.
AR-8941PL
In Commercial Distribution

  • 00888867132245 ()
  • M150AR8941PL0 ()
AR-8941PL

  • Orthopaedic fixation plate, non-bioabsorbable

Arthrex® - 00888867132207

LAPIDUS SYSTEM
ARTHREX, INC.
AR-8941LS
Not in Commercial Distribution

  • 00888867132207 ()
  • M150AR8941LS0 ()
AR-8941LS

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Arthrex® - 00888867132153

AIM GD FIX. SCRW PLANTAR LAPIDUS PLT
ARTHREX, INC.
AR-8941AS
In Commercial Distribution

  • 00888867132153 ()
AR-8941AS

  • Surgical drill guide, reusable

Arthrex® - 00888867132146

AIM GD,RT,PLANTAR LAPIDUS PLT
ARTHREX, INC.
AR-8941AR
In Commercial Distribution

  • 00888867132146 ()
AR-8941AR

  • Surgical drill guide, reusable

Arthrex® - 00888867132139

AIM GD,LFT,PLANTAR LAPIDUS PLT
ARTHREX, INC.
AR-8941AL
In Commercial Distribution

  • 00888867132139 ()
AR-8941AL

  • Surgical drill guide, reusable

Arthrex® - 00888867132122

LOW PROFILE SCREW, TI, 4.0MM X 80MM
ARTHREX, INC.
AR-8940-80
Not in Commercial Distribution

  • 00888867132122 ()
  • M150AR8940800 ()
AR-8940-80

  • Orthopaedic bone screw (non-sliding)

Arthrex® - 00888867132115

LOW PROFILE SCREW, TI, 4.0MM X 75MM
ARTHREX, INC.
AR-8940-75
Not in Commercial Distribution

  • 00888867132115 ()
  • M150AR8940750 ()
AR-8940-75

  • Orthopaedic bone screw (non-sliding)

Arthrex® - 00888867132108

LOW PROFILE SCREW, TI, 4.0MM X 70MM
ARTHREX, INC.
AR-8940-70
Not in Commercial Distribution

  • 00888867132108 ()
  • M150AR8940700 ()
AR-8940-70

  • Orthopaedic bone screw (non-sliding)

Arthrex® - 00888867132092

LOW PROFILE SCREW, TI, 4.0MM X 65MM
ARTHREX, INC.
AR-8940-65
Not in Commercial Distribution

  • 00888867132092 ()
  • M150AR8940650 ()
AR-8940-65

  • Orthopaedic bone screw (non-sliding)

Arthrex® - 00888867132085

LOW PROFILE SCREW, TI, 4.0MM X 55MM
ARTHREX, INC.
AR-8940-55
Not in Commercial Distribution

  • 00888867132085 ()
  • M150AR8940550 ()
AR-8940-55

  • Orthopaedic bone screw (non-sliding)

Arthrex® - 00888867132078

LOW PROFILE SCREW, TI, 4.0MM X 12MM
ARTHREX, INC.
AR-8940-12
In Commercial Distribution

  • 00888867132078 ()
  • M150AR8940120 ()
AR-8940-12

  • Orthopaedic bone screw (non-sliding)

Arthrex® - 00888867132061

LOW PROFILE SCREW, TI, 4.0MM X 10MM
ARTHREX, INC.
AR-8940-10
In Commercial Distribution

  • 00888867132061 ()
  • M150AR8940100 ()
AR-8940-10

  • Orthopaedic bone screw (non-sliding)

Arthrex® - 00888867132054

TENODESIS CONVERSION LOCK IMPLANT SYSTEM
ARTHREX, INC.
AR-8938P
In Commercial Distribution

  • 00888867132054 ()
  • M150AR8938P1 ()
AR-8938P

  • Polyester suture, non-bioabsorbable, multifilament

Arthrex® - 00888867132047

LO-PRO LOCK SCRW,TI,3.5MMX 80MM
ARTHREX, INC.
AR-8935L-80
Not in Commercial Distribution

  • 00888867132047 ()
  • M150AR8935L800 ()
AR-8935L-80

  • Orthopaedic bone screw (non-sliding)

Arthrex® - 00888867132030

LO-PRO LOCK SCRW,TI,3.5MMX 75MM
ARTHREX, INC.
AR-8935L-75
Not in Commercial Distribution

  • 00888867132030 ()
  • M150AR8935L750 ()
AR-8935L-75

  • Orthopaedic bone screw (non-sliding)

Arthrex® - 00888867132023

LO-PRO LOCK SCRW,TI,3.5MMX 70MM
ARTHREX, INC.
AR-8935L-70
Not in Commercial Distribution

  • 00888867132023 ()
  • M150AR8935L700 ()
AR-8935L-70

  • Orthopaedic bone screw (non-sliding)

Arthrex® - 00888867132016

LO-PRO LOCK SCRW,TI,3.5MMX 65MM
ARTHREX, INC.
AR-8935L-65
Not in Commercial Distribution

  • 00888867132016 ()
  • M150AR8935L650 ()
AR-8935L-65

  • Orthopaedic bone screw (non-sliding)

Arthrex® - 00888867132009

LO-PRO LOCK SCRW,TI,3.5MMX 55MM
ARTHREX, INC.
AR-8935L-55
Not in Commercial Distribution

  • 00888867132009 ()
  • M150AR8935L550 ()
AR-8935L-55

  • Orthopaedic bone screw (non-sliding)

Arthrex® - 00888867131996

LO-PRO SCRW,TI,3.5MMX 80MM
ARTHREX, INC.
AR-8935-80
In Commercial Distribution

  • 00888867131996 ()
  • M150AR8935800 ()
AR-8935-80

  • Orthopaedic bone screw (non-sliding)

Arthrex® - 00888867131989

LO-PRO SCRW,TI,3.5MMX 75MM
ARTHREX, INC.
AR-8935-75
In Commercial Distribution

  • 00888867131989 ()
  • M150AR8935750 ()
AR-8935-75

  • Orthopaedic bone screw (non-sliding)

Arthrex® - 00888867131972

LO-PRO SCRW,TI,3.5MMX 70MM
ARTHREX, INC.
AR-8935-70
In Commercial Distribution

  • 00888867131972 ()
  • M150AR8935700 ()
AR-8935-70

  • Orthopaedic bone screw (non-sliding)

Arthrex® - 00888867131965

LO-PRO SCRW,TI,3.5MMX 65MM
ARTHREX, INC.
AR-8935-65
In Commercial Distribution

  • 00888867131965 ()
  • M150AR8935650 ()
AR-8935-65

  • Orthopaedic bone screw (non-sliding)

Arthrex® - 00888867131958

LO-PRO SCRW,TI,3.5MMX 55MM
ARTHREX, INC.
AR-8935-55
Not in Commercial Distribution

  • 00888867131958 ()
  • M150AR8935550 ()
AR-8935-55

  • Orthopaedic bone screw (non-sliding)

Arthrex® - 00888867131941

LO-PRO SCRW,TI 3.5MMX 13MM
ARTHREX, INC.
AR-8935-13
In Commercial Distribution

  • 00888867131941 ()
  • M150AR8935130 ()
AR-8935-13

  • Orthopaedic bone screw (non-sliding)

Arthrex® - 00888867131934

LO-PRO SCRW,TI,3.5MMX 12MM
ARTHREX, INC.
AR-8935-12
In Commercial Distribution

  • 00888867131934 ()
  • M150AR8935120 ()
AR-8935-12

  • Orthopaedic bone screw (non-sliding)
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